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An Open-Label Trial of Oxytocin in Adolescents With Autism Spectrum Disorders

Primary Purpose

Autism Spectrum Disorders, Pervasive Developmental Disorders, ASD

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Intranasal Oxytocin

About this trial

This is an interventional treatment trial for Autism Spectrum Disorders focused on measuring Autism Spectrum Disorders, Pervasive Developmental Disorders, ASD, PDD, Oxytocin, Syntocinon, treatment

Eligibility Criteria

11 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria

Male and female outpatients ages 11-17 years
DSM-IV-TR PDD diagnosis of autistic disorder, Asperger's disorder, or PDD-NOS as established by clinical diagnostic interview and with the aid of the MGH ASD Symptom Checklist (MGH-ASD-SCL).
At least moderate severity of ASD impairment as measured by a raw score of ≥80 on the SRS and a severity score of ≥4 on CGI-PDD.
Participants and their parent/guardian must be able to speak and understand English sufficiently to comprehend the nature of the study and to allow for the completion of all study procedures required per protocol.
Subjects and their parent/guardian must be considered reliable reporters.
Each subject and their parent/guardian must understand the nature of the study and provide written informed assent/consent.
Subjects must be able to participate in mandatory blood draws.
Subjects with mood, anxiety, or disruptive behavior disorders will be allowed to participate in the study provided they do not meet any exclusionary criteria.

Exclusion Criteria

IQ <85
Total lack of spoken language
DSM-IV-TR PDD diagnosis of Rett's disorder or childhood disintegrative disorder.
Clinically unstable psychiatric conditions or judged to be at serious suicidal risk as determined by evaluating investigator.
History of substance use (except nicotine or caffeine) within past 3 months
Serious, stable or unstable systemic illness including hepatic, renal, gastroenterological, respiratory, cardiovascular (including ischemic heart disease), endocrinologic, neurologic, immunologic, or hematologic disease.
Subjects with severe hepatic impairment (LFTs > 3 times ULN) and those with severely impaired renal function (eGFR < 30).
Pregnant or nursing females.
Known hypersensitivity to oxytocin.
Severe allergies or multiple adverse drug reactions.
A non-responder or history of intolerance to oxytocin, after treatment at adequate doses as determined by the clinician.
Subjects with significant nasal pathology (including atrophic rhinitis, recurrent nose bleeds, and history of hypophysectomy).
Investigator and his/her immediate family defined as the investigator's spouse, parent, child, grandparent, or grandchild.
Currently enrolled or recently participated (within the past 6 months) in a clinical trial of intranasal oxytocin.

Sites / Locations

Massachusetts General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Oxytocin

Arm Description

Intranasal Oxytocin (brand name Syntocinon) will be administered daily (for a total daily dose of 48 IU) for 8 weeks.

Outcomes

Primary Outcome Measures

Change in ASD Symptoms Social Responsiveness Scales 2 (SRS-2) Scales From Baseline to Week 8

Change in ASD symptoms as measured by change from baseline on the Social Responsiveness Scale 2 (SRS-2) scale. The SRS-2 is a 65-item rating scale completed that is used to measure the severity of autism spectrum symptoms as they occur in natural settings. The SRS-2 School Age form is completed by a parent or guardian for patients ages 9-17 and the SRS-2 Adult Self-report is completed by patients ages 18-59. Total raw scores range from 0 to 195, with higher scores indicating increased symptom severity.

Number of Participants With ≥30% Reduction in SRS Raw Score and CGI Improvement Scores of ≤ 2 at Week 8

The SRS-2 is a 65-item rating scale completed that is used to measure the severity of autism spectrum symptoms as they occur in natural settings. The SRS-2 School Age form is completed by a parent or guardian for patients ages 9-17 and the SRS-2 Adult Self-report is completed by patients ages 18-59. Total raw scores range from 0 to 195, with higher scores indicating increased symptom severity. The Clinical Global Impression Improvement scale (CGI-ASD-I) is a clinician rated measure of ASD improvement. Improvement scores range from 1 (very much improved) to 7 (very much worse).

Secondary Outcome Measures

Full Information

NCT ID

NCT01931033

First Posted

August 22, 2013

Last Updated

September 12, 2023

Sponsor

Massachusetts General Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01931033

Brief Title

An Open-Label Trial of Oxytocin in Adolescents With Autism Spectrum Disorders

Official Title

An Open-Label Trial of Oxytocin in Adolescents With Autism Spectrum Disorders

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Completed

Study Start Date

October 2013 (undefined)

Primary Completion Date

February 22, 2016 (Actual)

Study Completion Date

February 22, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Massachusetts General Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This study is an 8-week open-label trial testing oxytocin nasal spray (Syntocinon) as a treatment for social impairment in adolescents with autism spectrum disorders (ASD). We hypothesize that oxytocin nasal spray will be safe, tolerable, and effective in improving the core symptoms of autism spectrum disorders in adolescents ages 11-17.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Autism Spectrum Disorders, Pervasive Developmental Disorders, ASD, PDD

Keywords

Autism Spectrum Disorders, Pervasive Developmental Disorders, ASD, PDD, Oxytocin, Syntocinon, treatment

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

8 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Oxytocin

Arm Type

Experimental

Arm Description

Intranasal Oxytocin (brand name Syntocinon) will be administered daily (for a total daily dose of 48 IU) for 8 weeks.

Intervention Type

Drug

Intervention Name(s)

Intranasal Oxytocin

Other Intervention Name(s)

Syntocinon

Primary Outcome Measure Information:

Title

Change in ASD Symptoms Social Responsiveness Scales 2 (SRS-2) Scales From Baseline to Week 8

Description

Time Frame

Week-8

Title

Number of Participants With ≥30% Reduction in SRS Raw Score and CGI Improvement Scores of ≤ 2 at Week 8

Description

Time Frame

Week-8

10. Eligibility

Sex

All

Minimum Age & Unit of Time

11 Years

Maximum Age & Unit of Time

17 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria Male and female outpatients ages 11-17 years DSM-IV-TR PDD diagnosis of autistic disorder, Asperger's disorder, or PDD-NOS as established by clinical diagnostic interview and with the aid of the MGH ASD Symptom Checklist (MGH-ASD-SCL). At least moderate severity of ASD impairment as measured by a raw score of ≥80 on the SRS and a severity score of ≥4 on CGI-PDD. Participants and their parent/guardian must be able to speak and understand English sufficiently to comprehend the nature of the study and to allow for the completion of all study procedures required per protocol. Subjects and their parent/guardian must be considered reliable reporters. Each subject and their parent/guardian must understand the nature of the study and provide written informed assent/consent. Subjects must be able to participate in mandatory blood draws. Subjects with mood, anxiety, or disruptive behavior disorders will be allowed to participate in the study provided they do not meet any exclusionary criteria. Exclusion Criteria IQ <85 Total lack of spoken language DSM-IV-TR PDD diagnosis of Rett's disorder or childhood disintegrative disorder. Clinically unstable psychiatric conditions or judged to be at serious suicidal risk as determined by evaluating investigator. History of substance use (except nicotine or caffeine) within past 3 months Serious, stable or unstable systemic illness including hepatic, renal, gastroenterological, respiratory, cardiovascular (including ischemic heart disease), endocrinologic, neurologic, immunologic, or hematologic disease. Subjects with severe hepatic impairment (LFTs > 3 times ULN) and those with severely impaired renal function (eGFR < 30). Pregnant or nursing females. Known hypersensitivity to oxytocin. Severe allergies or multiple adverse drug reactions. A non-responder or history of intolerance to oxytocin, after treatment at adequate doses as determined by the clinician. Subjects with significant nasal pathology (including atrophic rhinitis, recurrent nose bleeds, and history of hypophysectomy). Investigator and his/her immediate family defined as the investigator's spouse, parent, child, grandparent, or grandchild. Currently enrolled or recently participated (within the past 6 months) in a clinical trial of intranasal oxytocin.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gagan Joshi, MD

Organizational Affiliation

Massachusetts General Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Massachusetts General Hospital

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

12. IPD Sharing Statement

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An Open-Label Trial of Oxytocin in Adolescents With Autism Spectrum Disorders

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